510(k) K211471

Balanced Knee System Uni by Ortho Development Corporation — Product Code HSX

K211471 is an FDA 510(k) premarket notification submitted by Ortho Development Corporation for the device "Balanced Knee System Uni". The FDA issued a decision of Substantially Equivalent on December 16, 2021. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Ortho Development Corporation has at least 10 other 510(k) clearances on record.